Table 1.

Overview of GCP-regulations valid for EU-member states and the USA

Country	Regulation	Legal status
EU	EU-GCP “Directive 2001/20/EC” [6]	Binding law
EU	Guidance documents of the European Commission (i.e. European Commission EUDRACT 2004 [9], European Commission Eudravigilance 2004 [10])	Guidance on the implementation of requirements in Directive 2001/20/EC
EU (individual member states)	National laws of EU member states (e.g. the Austrian “Arzneimittelgesetz von 1983, Fassung 2013” [7])	National laws, implementing Directive 2001/20/EC
EU and USA	ICH-GCP-guidelines [4]	Recommendations, aiming for harmonisation of GCP between USA, Europe and Japan
USA	Code of Federal Regulations (CFR Title 21) [8]	Binding laws and regulations
USA	FDA GCP/Clinical Trial Guidance Documents [11]	Guidance on the implementation of GCP-regulations